Kornimate/medical-research-clean huggingface dataset:
feasibility study of remote support for implantable pulse generator (ipg)/implantable cardioverter defibrillator (icd) implant

Conditions: Bradycardia; Sudden Cardiac Arrest

Summary: the purpose of this study is to gain real world, live implant experience with the remote implant support system. this system is intended to provide the technical support for device implants from a remote location through telepresence (audio and video) and remote control. specifically, the goals of this study are to corroborate bench testing, assess the performance of the system, gain understanding of the workflows, customer experience, and logistics. the intent of the remote support model is to provide the same support that would typically be provided by a local support person, only remotely. as such, the remote support person would only perform actions that a local support person would routinely do under the direction of a physician. this may involve observing patient data, providing technical support and advice, and performing testing and device reprogramming via remote control of the programmer.


Eligibility criteria:
inclusion criteria: * planned ipg implant or planned icd (without crt) implant * signed informed consent exclusion criteria: * pacing dependency * defibrillation threshold testing planned * basal ventricular rate \>110 beats per minute * younger than 18 years * pregnant * currently involved in another ipg or icd related clinical trial

Keywords: pacemaker defibrillator remote consultation
deep brain stimulation for obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: the goal of this clinical trial is to evaluate the treatment method of deep brain stimulation (dbs) in patients diagnosed with severe and treatment-resistant obsessive-compulsive disorder (ocd). dbs will be administered into the brain area of the bed nucleus of stria terminalis (bnst). the main research questions are: * does active dbs in bnst reduce ocd symptoms (primary outcome)? * does active dbs in bnst reduce anxiety or depressive symptoms and improve the level of daily function? the participants will be randomized to active or sham dbs in the bnst for six months and we will measure the outcomes before dbs surgery, and six months post-surgery. after the randomization phase, the participants will enter an open-label phase and receive continuous dbs in bnst. yearly follow-ups will be conducted. the outcomes will be measured through interviews using validated psychometric scales.


Eligibility criteria:
inclusion criteria: * ocd diagnosed according to the criteria in the diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv). * the patients should have received at least 16 sessions of cognitive behavioral therapy, tried three different serotonergic antidepressants in adequate doses for three months, and one serotonergic antidepressant in combination with a neuroleptic drug. * severe ocd symptoms: ybocs ≥ 25 points. * substantial incapacity because of his/her symptoms. * duration of symptoms: 5 years minimum. * understand the consequences of participation in the study and give informed written consent. exclusion criteria: * not being able to understand the consequences of the treatment. * diagnosed with intellectual disability according to dsm-iv. * not meeting the requirements for the neurosurgery procedure.

Keywords: obsessive-compulsive disorder deep brain stimulation randomized controlled trial
prolonged preoperative rehabilitation in acl rupture.

Conditions: Anterior Cruciate Ligament Injuries

Summary: rupture of the anterior cruciate ligament is a serious and common injury. in young athletes, surgical reconstruction of the anterior cruciate ligament by autograft with hamstrings or patellar ligament is widely used. despite relatively standardized medical, surgical, and paramedical management, the results after acl ligamentoplasty are not entirely satisfactory in term of return to sport. recovery of the quadriceps strength is recognized as one of the decision-making criteria allowing the return to sport; however, significant muscle deficits are frequent at the time of return to sport. if the postoperative management is well codified, focused on muscle strengthening and neuromuscular retraining, some studies have addressed the value of preoperative rehabilitation, and recommend a good preoperative muscular recovery of knee extensors and flexors, to obtain better postoperative results at the stage of the return to sports. these results suggest that preoperative quadriceps strength should be considered as a predictor of the athletes' ability to return to sport activities. it is estimated that around 10 to 30% of patients with preoperative deficits and could benefit from additional rehabilitation. it can then be assumed that if the preoperative deficit is smaller, the postoperative deficit will also be smaller. this is the challenge of preoperative rehabilitation. there are a few studies on preoperative rehabilitation which allow a gain in strength of knee extensors and flexors. however, the rehabilitation protocols applied to patients highly varied and there is no consensus on one protocol. the potential improvement is in the range of 10 to 20%. the hypothesis of the study is that an optimal recovery of the strength of the preoperative knee extensors and flexors would reduce the postoperative deficit, thus improving the return to sport. in the absence of reliable information on the frequency of muscle weakness in preoperative patients, we will conduct a preliminary study to obtain these data as well as the potential gain in strength with our preoperative rehabilitation protocol.


Eligibility criteria:
inclusion criteria: * acute acl injury (\< 4 weeks) before surgical treatment * patient given written consent to participate in the study, * patient able to understand the protocol and willing to comply with its rules. * social security affiliated exclusion criteria: * age \ 45 years, * acl rupture associated with fracture or complex meniscal tear or lesion to the lateral collateral ligament or posterior cruciate ligament * history of ligament surgery on the affected and non-affected knee. * fracture * isokinetic contraindications : cardiorespiratory, metabolic, neurological, cancer or hematological pathology contraindicating physical activity, long term steroid use (\> 3 months), pregnancy, skin problems under load cell, osteoporosis, anticoagulants * patient under the protection of adults * informed consent not obtained

Keywords: rehabilitation preoperative strength isokinetic anterior cruciate ligament
a real-world study of inclisiran adherence, treatment patterns, patient characteristics, and effectiveness in ascvd patients with hypercholesterolemia, ascvd-risk equivalent patients with hypercholesterolemia and familial hypercholesterolemia

Conditions: Atherosclerotic Cardiovascular Disease; Hypercholesterolemia

Summary: this was a descriptive, non-interventional, retrospective cohort study among patients with atherosclerotic cardiovascular disease (ascvd) and hypercholesterolemia, ascvd-risk equivalent (ascvd-re) or familial hypercholesterolemia (fh) administered inclisiran in a real-world setting in austria.


Eligibility criteria:
inclusion criteria: * patients who were 18 years or older. * signed informed consent was obtained. * patients who received at least one inclisiran injection in the identification period. * patients with at least one diagnosis of ascvd, ascvd-re or fh diagnosis prior to index date. * patients with at least one low-density lipoprotein cholesterol (ldl-c) measurement of 70 milligrams per deciliter (mg/dl) or greater, within 6 months prior to index date. ascvd was defined as previous diagnosis of coronary artery disease (cad), peripheral artery disease (pad) or cerebrovascular disease (cvd). ascvd-re was defined as: no previous diagnosis of ascvd at any time on the patient chart and they met at least one of the following criteria: * diagnosis of type ii diabetes mellitus (t2dm). * diagnosis of type i diabetes mellitus (t1dm) of long duration (greater than 20 years). * 10-year risk of 20% or greater by framingham risk score. exclusion criteria: • none.
flavopiridol, gemcitabine, and irinotecan in treating patients with unresectable or metastatic solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: this phase i trial is studying the side effects and best dose of flavopiridol when given together with gemcitabine and irinotecan in treating patients with unresectable or metastatic solid tumors. drugs used in chemotherapy, such as flavopiridol, gemcitabine, and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells

primary objectives: i. determine the maximum tolerated dose and recommended phase ii dose of flavopiridol in combination with gemcitabine and irinotecan in patients with unresectable or metastatic solid tumors. ii. determine the toxicity profile of this regimen in these patients. outline: this is a dose-escalation study of flavopiridol. patients receive gemcitabine iv over 30 minutes followed by irinotecan iv over 30 minutes on days 1 and 15. patients also receive flavopiridol iv over 60 minutes on days 2 and 16. treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Eligibility criteria:
inclusion criteria: * histologically confirmed solid tumor that is metastatic or unresectable * standard curative or palliative measures do not exist or are no longer effective * no known brain metastases * performance status - ecog 0-2 * performance status - karnofsky 60-100% * more than 12 weeks * wbc ≥ 3,000/mm\^3 * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * bilirubin normal * ast and alt ≤ 2.5 times upper limit of normal * creatinine normal * creatinine clearance ≥ 60 ml/min * no venous thrombosis within the past 6 months * no thrombotic cerebrovascular accident within the past 6 months * no myocardial infarction within the past 6 months * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia * no ongoing or active infection * no prior allergic reaction attributed to compounds of similar chemical or biological composition to study agents * no other concurrent uncontrolled medical condition that would preclude study participation * no psychiatric illness or social situation that would preclude study participation * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * prior biologic therapy allowed * more than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * prior endocrine therapy allowed * more than 4 weeks since prior radiotherapy and recovered * prior surgery allowed * no other concurrent investigational agents * no concurrent combination antiretroviral therapy for hiv-positive patients
in-vivo response of p. falciparum to antimalarial treatment in hiv-infected and hiv-uninfected adults

Conditions: Malaria; HIV; AIDS

Summary: plasmodium falciparum malaria and hiv are among the most important infectious diseases in sub-saharan africa. approximately two-thirds of the estimated 35 million hiv infected persons live in sub-saharan africa. of the 300-500 million annual cases of malaria infection occurring worldwide, about 90% of p. falciparum infections occur in sub-saharan africa, resulting in approximately 1 million deaths, mostly in children under five years of age. it is clear that hiv and malaria are responsible for substantial disease, suffering, and an enormous economic burden on the people who can least afford it. although a study in 1993 in tanzania showed significantly higher prevalence of malaria infections in hiv-positive compared to hiv negative adults, until recently there have been few studies showing any association between the two infections. we conducted a study to measure the efficacy of the then-first line antimalarial drug (sulfadoxine-pyrimethamine) among patients in three study arms: those who were hiv negative, those who were hiv infected with cd4 cell counts \ = 200. our hypothesis is that patients with hiv infection and low cd4 cell count will not respond to antimalarial therapy as well as patients who are hiv infected with higher cd4 cell counts or who are hiv negative.

the study was conducted at siaya district hospital, in nyanza province, kenya. non-pregnant adults who provided consent to participate, who were found to have pure plasmodium falciparum malaria parasitemia with at least 500 asexual parasites per microliter, and who agreed to undergo hiv counseling and testing were eligible for participation. clients were then followed with repeat physical examinations and blood smears on day 1,2,3,4,7,14,21 and 28 and any non-scheduled day when they were sick. those that failed therapy were treated with quinine to clear parasitemia. samples were also taken to measure reinfection vs. recrudescence, pharmacokinetics, and antifolate resistance markers.

Eligibility criteria:
inclusion criteria: 18 years of age or older, not pregnant. are able to make all follow-up visits. are able to understand and give informed consent. have a history of fever in past 24hrs or current axillary temperature of ³ 37.5c. have an unmixed infection with p. falciparum of at least 500 asexual parasites/mm3 as determined by microscopic examination of thick and/or thin peripheral blood smears. do not have any evidence of severe or complicated malaria (e.g., cerebral malaria, hb \< 5 g/dl, signs and symptoms of congestive heart failure) that would require hospitalisation for treatment. have no reported allergy to sulfa drugs. agree to hiv testing and receiving the results. exclusion criteria: less than 18 yrs old. pregnant. history of allergic reactions to sulfa drugs. have severe or complicated malaria. no history of fever. plan to leave siaya in next month. do not agree to hiv testing.

Keywords: malaria hiv aids drug efficacy kenya africa sulfadoxine pyirmethamine fansidar
comparative effect of scapular stabilization vs thoracic extension exercises in young adults with text neck syndrome.

Conditions: Neck Syndrome; Forward Head Posture

Summary: the aim of the study is to compare the effect of scapular stabilization versus thoracic extension exercises on pain, disability, range of motion, and cranio-vertebral angle in young adults with text neck syndrome.

text neck has emerged as a widespread modern epidemic that affects people of all ages, particularly younger populations, as they are exposed to handheld mobile device use for several hours a day beginning at a very early age. the relation between the posture due to handheld mobile device use and neck pain is still debatable. to manage the maladaptive posture of the cervical spine, indirect treatment instead of direct treatment of the neck can be used, which is the basis for the concept of regional interdependence, i.e., the cause of pain becomes the cause of damage to other body parts. therefore, not treating the damaged part, but indirectly treating the area of cause can alleviate the symptoms. a bio-dynamic relationship between the cervical and thoracic spine is associated with exercise, an important factor causing neck pain. therefore, many clinicians pay attention to the thoracic spine of patients with neck pain and recommend thoracic extension exercises. on the other hand, many researchers recommended scapular stabilization exercise as a recovery treatment for imbalanced scapular muscles caused by forward head posture. this study investigates how exercise programs not directly applied to the cervical spine affect people with text neck syndrome. the significance of the current study is to evaluate the comparison between concentric and eccentric exercise which is previously rarely investigated.

Eligibility criteria:
inclusion criteria: * both male and female participants with forward head posture or text neck syndrome * participants with neck pain from the past three months * smart-phones must be used for at least ≥3 hours each day * participants with craniovertebral angle \<53° will be included in this study exclusion criteria: * history of cervical and thoracic spine surgery within the past three months * serious pathological conditions within the past three months * congenital spinal anomalies, or rheumatoid arthritis * neurological signs and severe psychological disorders

Keywords: craniovertebral angle scapular stabilization exercises thoracic extension text neck syndrome range of motion pain disability
non-inferiority trial of two snake antivenoms in car (paves)

Conditions: Snake Bites

Summary: interventional, individually randomized, double (e.g. investigator and participant) blinded, parallel two-arm, non-inferiority trial to assess the efficacy of echitabplus-icp compared to fav-africa for the treatment of snakebite with envenoming.

the study is designed as a randomized, double-blind, non-inferiority trial among patients suffering envenoming following snakebite in paoua, central african republic. the primary aim of the study is to assess the non-inferiority of echitabplus-icp compared to fav-africa, at preventing a composite primary endpoint consisting of death from any cause, need for blood transfusion or need for a third dose of antivenom. a total of 196 patients will be individually randomized in a 1:1 ratio to receive fav-africa or echitabplus-icp. the first dose of intervention antivenom will be administered at study enrollment, and the need for further doses will be judged by clinical exam and the 20 minute wbct, following the protocol. all other necessary medical care will be provided as per routine in the paoua prefectural hospital. study followup and surveillance for adverse events and serious adverse events will continue until 28 days after the initial dose of antivenom. unique identification numbers will be allocated by an individual independent of the study team using a computer-generated random number list using permuted blocks of random sizes. block sizes will not be disclosed to reduce predictability of the random sequence and ensure allocation concealment. the site principal investigator who will oversee randomization will be given a set of sequentially numbered silver coated booklets. the site principal investigator will be instructed to assign the next sequential randomization code noted in the booklet to each eligible participant as (s)he is enrolled. study antivenoms will be prepared by the unblinded study pharmacist, and will be provided to the clinical staff in identical presentations. group assignment will remain concealed from study personnel, investigators, and participants for the entire study period. the data and safety monitoring board (dsmb) will also be masked to the group assignment. the dsmb will remain masked unless otherwise deemed necessary by the dsmb members for any safety related issues. investigators conducting the final analysis will remain masked to the group assignment until the end of the analysis.

Eligibility criteria:
inclusion criteria: * present within 72 hours of snakebite * have signs and symptoms of grade 2 envenoming (oedema beyond the elbows or knees, bleeding at site of bite, bleeding from the gums or hematuria) or grade 3 envenoming (oedema to the shoulders or hips, or serious bleeding - epistaxis, hemoptysis, gastrointestinal bleeding) * lack of coagulation of blood at 20 minutes in a dry vacutainer tube (abnormal 20 minute wbct) exclusion criteria: * known allergy to horses or heterologous proteins of equine origins * pregnancy * have received antivenom since the snakebite
parental involvement and children's extra-familial contexts

Conditions: Prevention of Drug Abuse Risk

Summary: parental involvement has been shown to be a robust predictor of child conduct problems (cp) and drug use risk in childhood and adolescence, but relatively little attention has been paid to the role of parental involvement in relation to child problem behavior during the transition to school-age, when children are spending more time in school, after-care settings, and in the neighborhood. concomitantly, as children transition from preschool to school-age, there is evidence to suggest that the quality and organization of schools, after-school care, and neighborhoods play an increasingly important role in the emergence of children's cp and drug use risk. specifically, we will address: 1) the extent to which the quality of school environments, after-school care, and neighborhoods are associated with the emergence of cp during the early school-age period; 2) how parental involvement in the toddler and preschool period may be associated with parental involvement and monitoring in extra-familial contexts in the early school-age years; 3) how parental involvement in schools, after-care, and the neighborhood, may moderate relationships between extra-familial factors and children's cp; and 4) whether a parenting intervention can increase parental involvement in school, after-care, and neighborhood contexts and decrease risk of children's subsequent cp. these issues will be tested with an existing sample of 731 ethnically-diverse children from urban, suburban, and rural sites. as all families in the study were recruited based on the presence of sociodemographic, family, and child risk factors, the cohort of children are at high risk for displaying a persistent trajectory of clinically-meaningful cp and drug use risk. thus, the study has the potential to fill a much-needed void on associations between extra-familial contexts and risk for early-starting cp and later problem behavior during the early school-age years. equally critical, the study can provide data on the potential moderating influence of involved parenting, its malleability for families facing multiple adversities, and whether family-based interventions can make a difference for children facing multiple adversities.


Eligibility criteria:
inclusion criteria: * previously enrolled sample of 731 children recruited on the basis of prior screening for socioeconomic, family, and child risk factors at age 2 exclusion criteria: * all children and families needed to have a child 2-3 years of age with multiple socioeconomic, family, and child risk factors.

Keywords: drug use, antisocial behavior, early intervention, prevention